Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medinol, Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
184 daysmedian FDA review time
445 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173581 | Gallant PTCA Dilatation Catheter | Medinol, Ltd. | 2018-01-25 | 66 | 0 |
| K162434 | NC Gallant PTCA Catheter | Medinol, Ltd. | 2017-01-19 | 141 | 0 |
| K150487 | X-Suit NIR Biliary Metallic Stent | Medinol, Ltd. | 2016-02-12 | 352 | 0 |
| K081956 | MEDINOL X-SUIT NIR BILIARY METALLIC STENT | Medinol, Ltd. | 2009-01-09 | 184 | 0 |
| K002130 | NIR BILIARY STENT | Medinol, Ltd. | 2000-10-30 | 108 | 0 |
| K973171 | NIR BILIARY STENT | Medinol, Ltd. | 1998-11-13 | 445 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda